QC Microbiology Technical Lead

Harba Solutions Inc.; Brentwood (MO); On-site; USD 120,000 - 180,000; Full time

Job summary

Harba Solutions Inc. seeks an experienced QC Microbiology Technical Lead to oversee laboratory operations, testing, data review, and documentation. You will lead investigations, develop CAPAs, and drive continuous improvement in a regulated environment.

Responsibilities include leading OOS investigations, authoring SOPs, and mentoring junior staff while ensuring compliance with global regulations and quality systems. This is a hands-on leadership role in a dedicated microbiology lab.

Qualifications

• Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific discipline.
• 7+ years of experience in pharmaceutical or biotechnology quality laboratories.
• Strong knowledge of cGMP and global regulatory requirements (USP, EP, ICH, EU Annex 1).
• Experience developing, validating, verifying, and transferring microbiological and environmental monitoring methods.
• Strong technical writing, communication, organizational, and problem-solving skills.
• Ability to create and review clear, accurate, and inspection-ready documentation.
• Demonstrated ability to work independently while providing technical leadership.

Responsibilities

• Provide technical oversight of QC Microbiology activities across endotoxin, bioburden, microbial ID, environmental monitoring, and related assays.
• Conduct testing and ensure compliance with cGMP, FDA, USP, EP, ICH, EU Annex 1, and applicable standards.
• Perform data review and approval to support daily laboratory operations and ensure compliant results.
• Author, review, and approve SOPs, protocols, specs, validation reports, and impact assessments.
• Lead microbiological OOS and deviation investigations including root cause analysis and CAPA.
• Promote risk-based and data-driven approaches to improve investigation quality and efficiency.
• Provide training, coaching, and mentorship to junior staff.
• Support strategic lab initiatives to improve efficiency, technology, and capabilities.
• Use microbiological data to support risk-based decisions for aseptic processing and manufacturing practices.
• Lead projects involving new capabilities, tech implementation, method development, validation, and lifecycle programs.
• Collaborate with cross-functional teams to align lab activities with business and regulatory needs.

Skills

cGMP knowledge

Regulatory knowledge

Technical writing

Communication

Problem-solving

Education

Bachelor’s degree in Microbiology/Biology/Biochemistry

Tools

MODA or similar environmental monitoring systems

Job description

We are seeking an experienced QC Microbiology Technical Lead to provide technical oversight of microbiology laboratory operations. This role will serve as a functional leader on the bench, supporting testing, data review and approval, investigations, documentation, and continuous improvement initiatives.

Key Responsibilities

• Provide technical oversight and expertise across QC Microbiology activities, including Endotoxin, Bioburden, Microbial Identification, Environmental Monitoring, and other microbiological assays.
• Perform and support laboratory testing while ensuring activities are conducted in compliance with cGMP, GDP, FDA, USP, EP, ICH, EU Annex 1, DEA, OSHA, and other applicable regulations and standards.
• Perform data review and approval to support daily laboratory operations and ensure accurate, compliant results.
• Author, review, and approve SOPs, protocols, specifications, validation reports, impact assessments, and other technical documentation.
• Lead and support microbiological OOS and deviation investigations, including root cause analysis, risk assessment, and development of effective CAPAs.
• Promote risk-based and data-driven approaches to improve investigation quality, compliance, and efficiency.
• Provide training, coaching, and mentorship to junior laboratory personnel.
• Support strategic laboratory initiatives designed to improve efficiency, technology, and overall laboratory capabilities.
• Use microbiological data to support risk-based decision-making related to aseptic processing, facility controls, environmental monitoring, and manufacturing practices.
• Lead and support projects involving new laboratory capabilities, technology implementation, method development, validation, and lifecycle programs.
• Collaborate with cross-functional teams to ensure laboratory activities align with business priorities, regulatory expectations, and manufacturing needs.

Required Qualifications

• Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related scientific discipline.
• 7+ years of experience in pharmaceutical or biotechnology quality laboratories.
• Strong knowledge of cGMP and global regulatory requirements, including USP, EP, ICH, and EU Annex 1.
• Experience developing, validating, verifying, and transferring microbiological and environmental monitoring methods.
• Strong technical writing, communication, organizational, and problem-solving skills.
• Ability to create and review clear, accurate, and inspection-ready documentation.
• Demonstrated ability to work independently while providing technical leadership and guidance to laboratory teams.

Preferred Qualifications

• Experience supporting both development and commercial manufacturing environments.
• Previous experience working in a CDMO, multi-product, or biologics manufacturing facility.
• Experience using MODA or similar environmental monitoring/data management systems.
• Experience leading laboratory investigations, process improvements, or implementation of new technologies.